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So what should an advertisement recruiting trial subjects say? W. Parker Nolen, MBA, IRB administrator for St. Josephs Hospital in Atlanta, recommends the following:
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IRBs are not required to review stand-alone HIPAA waivers as part of their oversight of research subject protections even if their written policies and procedures indicate they will review any written documentation provided to potential study participants, the U.S. Food and Drug Administration (FDA) clarified in a recent guidance document issued Oct. 21, 2003, and published in the Nov. 7 issue of the Federal Register.
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Its pretty much a given that computer-based recordkeeping will play a part in a clinical trial.
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A recent study by the Maternal & Child Health Policy Research Center makes clear that when it comes to caring for adolescents, the health care system is not doing a very good job.
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More than two years after the terrorist attacks in New York City and Washington, DC, and despite $1.8 appropriated by Congress to revitalize the countrys public health system, some progress has been made, but not nearly enough, according to a report prepared by Trust for Americas Health.
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With commercial health plans exiting from the Medicaid market in the last few years, state Medicaid programs are becoming more dependent on Medicaid-only plans. But are Medicaid-only plans able to provide high-quality cost-effective care and remain in business for the long-term?
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Rather than age or severity of illness, the strongest determinants of the withdrawal of ventilation in critically ill patients are often the physicians perception that the patient preferred not to use life support or had a low chance of survival in the intensive care unit, a recent study1 by the Canadian Critical Care Trials Group and the Level of Care Study Investigators has found.
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Studies of terminally ill patients indicate that a small number of them want the option of physician-assisted suicide (PAS) or other means of controlling the manner in which they die. Yet with PAS legal in only one state, most will not have that option.
